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Drug Category: Pain and inflammation

Medication Class/Individual Agents: Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)

I. Prior-Authorization Requirements

 Non-Selective Nonsteroidal Anti-Inflammatory Drugs – Acetic Acid Derivatives

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

etodolac test  
etodolac extended-release PA  
indomethacin 20 mg, 40 mg Tivorbex PA  
indomethacin 25 mg, 50 mg test  
indomethacin extended-release test  
indomethacin suppository Indocin test  
indomethacin suspension Indocin PA  
nabumetone test  
sulindac test  
tolmetin PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

Risk factors for NSAID-related GI toxicity:

  • Age ≥ 60 years, history of gastric or duodenal ulcer, history of gastrointestinal (GI) bleed, perforation or obstruction, concurrent use of anticoagulants, aspirin (including low doses for cardiovascular prophylaxis), corticosteroids, high daily NSAID doses.

To avoid or minimize GI toxicity:

  • Lowest effective dose should be prescribed for the shortest possible duration.
  • GI toxicity may be lower with ibuprofen, naproxen, ketoprofen, diclofenac, and higher with indomethacin, flurbiprofen, and piroxicam.

If risk factors are present for NSAID-related GI toxicity as above, consider:

  • Etodolac, nabumetone and meloxicam, all of which are preferential COX-2 inhibitors; however, with higher doses of etodolac and nabumetone, preferential inhibition of COX-2 is diminished.
  • Highly selective COX-2 inhibitor (see table below).
  • An antisecretory agent (PPI or misoprostol) with a non-selective NSAID.

Risk factors for NSAID-related renal toxicity:

  • Preexisting renal disease, severe CHF, liver disease, or diuretic use

 Ankylosing Spondylitis (AS)/Osteoarthritis(OA)/Rheumatoid Arthritis (RA) Dosing for celecoxib:

  • Celecoxib: AS: 200 mg QD or 100 mg BID, up to 400 mg/day; OA: 200 mg QD or 100 mg BID; RA: 100-200 mg BID

Sulfonamide Allergy:

  • Celecoxib is a sulfonamide derivative. The labeling for celecoxib states that use is contraindicated in sulfonamide-allergic patients.
 

 Non-Selective Nonsteroidal Anti-Inflammatory Drugs – Anthranilic Acid Derivatives

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

meclofenamate PA  
mefenamic acid test  

 Non-Selective Nonsteroidal Anti-Inflammatory Drugs – Enolic Acid Derivatives

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

meloxicam capsule Vivlodex PA  
meloxicam suspension PA  
meloxicam tablet Mobic # test  
piroxicam Feldene # test  

 Non-Selective Nonsteroidal Anti-Inflammatory Drugs – Phenylacetic Acid Derivatives

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

diclofenac / misoprostol Arthrotec # PA   - < 60 years
diclofenac 1% gel Voltaren Gel BP test  
diclofenac 18 mg, 35 mg capsule Zorvolex PA  
diclofenac 25 mg capsule Zipsor PA  
diclofenac extended-release Voltaren-XR # test  
diclofenac powder for solution Cambia PA  
diclofenac tablet test  
diclofenac topical patch Flector BP PA  
diclofenac topical solution Pennsaid PA  

 Non-Selective Nonsteroidal Anti-Inflammatory Drugs – Propionic Acid Derivatives

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

fenoprofen capsule Nalfon PA  
fenoprofen tablet PA  
flurbiprofen test  
ibuprofen * test  
ibuprofen / famotidine Duexis PA   - < 60 years
ibuprofen powder PA  
ketoprofen test  
ketoprofen extended-release PA  
ketorolac nasal spray Sprix PA  
ketorolac tablets and injection PA   - > 20 units/month
naproxen / esomeprazole Vimovo PA   - <60 years
naproxen capsule, tablet * test  
naproxen controlled-release Naprelan CR PA  
naproxen enteric coated Naprosyn EC # test  
naproxen suspension PA   - ≥ 12 years
oxaprozin Daypro # test  

 Non-Selective Nonsteroidal Anti-Inflammatory Drugs – Salicylic Acid Derivative

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

diflunisal test  
salsalate PA  

 Nonsteroidal Anti-Inflammatory Drugs – COX-2 (Highly Selective) NSAIDs

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

celecoxib Celebrex # test  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 

II. Therapeutic Uses

FDA-approved:

  • Acute pain
  • Ankylosing spondylitis 
  • Familial adenomatous polyposis (FAP) 
  • Juvenile rheumatoid arthritis
  • Mild-to-moderate pain
  • Moderate to moderately-severe pain
  • Osteoarthritis
  • Primary dysmenorrhea
  • Rheumatoid arthritis

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • Additional criteria may apply depending upon diagnosis or requested medication (see below). 

 

 

Cambia

  • Documentation of the following is required:
    • diagnosis of migraine; and
    • one of the following:
      • medical records documenting an inadequate response or adverse reaction to three different NSAIDs, one of which must be diclofenac sodium; or
      • for members with a swallowing disorder or condition affecting the ability to swallow tablets, an inadequate response or adverse reaction to ibuprofen suspension and naproxen suspension.

  

diclofenac/misoprostol for members < 60 years of age

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • medical records documenting an inadequate response or adverse reaction with concurrent therapy of diclofenac (minimum of 50 mg twice daily) and misoprostol (minimum of 200 mcg twice daily).

  

diclofenac topical patch and diclofenac topical solution

  • Documentation of the following is required:
    • diagnosis of acute pain (caused by minor strains, sprains, and contusions) or osteoarthritis; and
    • an inadequate response or adverse reaction to diclofenac 1% gel; and
    • one of the following:
      • previous history of a major gastrointestinal (GI) bleed, perforation, or obstruction; or
      • previous history of a peptic ulcer, hemorrhagic gastritis, hemorrhagic gastropathy, or erosive esophagitis or esophageal varices; or
      • concomitant therapy for an anticoagulant or antiplatelet agent (including aspirin), or chronic oral corticosteroid; or
      • renal insufficiency; or
      • concomitant diagnosis of GERD; or
      • medical necessity for a topical formulation; or
      • an inadequate response, adverse reaction, or contraindication to acetaminophen and at least two different generic NSAIDs (one being a generic diclofenac product).

 

Duexis for members < 60 years of age

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • medical records documenting an inadequate response or adverse reaction with concurrent therapy of ibuprofen (minimum of 800 mg three times daily) and famotidine (minimum of 20 mg three times daily).

 

etodolac ER, ketoprofen ER, naproxen CR

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • medical necessity for an extended-release formulation over the immediate release equivalent.

   

fenoprofen, meclofenamate, salsalate, tolmetin

  • Documentation of the following is required:   
    • an appropriate diagnosis; and
    • an inadequate response or adverse reaction to three different oral NSAIDs.

 

ibuprofen powder

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives cannot be used.

 

Indocin suspension for all ages, meloxicam suspension for all ages, and naproxen suspension for members ≥ 12 years of age

  • Documentation of the following is required:                   
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to ibuprofen suspension; and
    • clinical rationale for the use of a suspension formulation. 

     

ketorolac (tablets and injection) > 20 units/month

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response or adverse reaction to three different NSAIDs; and
    • clinical rationale for exceeding FDA-approved dosing/duration.  

  

Sprix

  • Documentation of the following is required:
    • diagnosis of moderate to moderately severe pain; and
    • one of the following:
      • medical necessity for a non-oral NSAID formulation; or
      • an inadequate response or adverse reaction to two different NSAIDs and medical records documenting an inadequate response or adverse reaction to ketorolac tablets or injection; and
    • one of the following:
      • request is within quantity limit of 5 bottles/30 days; or
      • clinical rationale for exceeding FDA-approved dosing/duration.

 

Tivorbex

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response or adverse reaction to indomethacin 25 mg or 50 mg; and
    • an inadequate response or adverse reaction to two other different NSAIDs; and
    • request is within quantity limit of 90 units/30 days.

       

Vimovo for members < 60 years of age

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • medical records documenting an inadequate response or adverse reaction with concurrent therapy of naproxen (minimum of 375 mg twice daily) and omeprazole (minimum of 20 mg twice daily).

    

Vivlodex

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response or adverse reaction to meloxicam tablet; and
    • an inadequate response or adverse reaction to two other different NSAIDs; and
    • request is within quantity limit of 30 units/30 days.

    

Zipsor, Zorvolex

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response or adverse reaction to diclofenac sodium; and 
    • an inadequate response or adverse reaction to two other different NSAIDs.

 

Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 09/2002

Last Revised Date: 07/2019


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Last updated 07/15/19